FDA 510(k) Applications Submitted by Philips Medical Systems Nederland B.V.

FDA 510(k) Number Submission Date Device Name Applicant
K250181 01/22/2025 AV Viewer Philips Medical Systems Nederland B.V.
K242879 09/23/2024 dS Knee Coil 8ch 1.5T Philips Medical Systems Nederland B.V.
K211764 06/08/2021 Vereos PET/CT Philips Medical Systems Nederland B.V.
K242001 07/09/2024 Philips VSC-MEDlib Philips Medical Systems Nederland B.V.
K130021 01/03/2013 PHILIPS HERCEPTEST DIGITAL SCORE PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K241871 06/27/2024 Philips IntelliSite Pathology Solution Philips Medical Systems Nederland B.V.
K242848 09/20/2024 Philips IntelliSite Pathology Solution 5.1 Philips Medical Systems Nederland B.V.
K243871 12/17/2024 Philips IntelliSite Pathology Solution 5.1 Philips Medical Systems Nederland B.V.
K172174 07/19/2017 Philips IntelliSite Pathology Solution Philips Medical Systems Nederland B.V.
DEN160056 12/01/2016 Philips IntelliSite Pathology Solution Philips Medical Systems Nederland B.V.
K121296 04/30/2012 INTERVENTIONAL WORKSPOT PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K121772 06/15/2012 ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K121781 06/18/2012 ECHONAVIGATOR RELEASE 1 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K192914 10/15/2019 Stimuplex Onvision System Philips Medical Systems Nederland B.V.
K180940 04/10/2018 KODEX EPD System Philips Medical Systems Nederland B.V.
K200713 03/18/2020 EchoNavigator Philips Medical Systems Nederland B.V.
K232030 07/07/2023 Ingenia Elition R5.7.1 SP4 MR Systems Philips Medical Systems Nederland B.V.
K223458 11/16/2022 Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems Philips Medical Systems Nederland B.V.
K183063 11/05/2018 Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems Philips Medical Systems Nederland B.V.
K173079 09/29/2017 Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 Philips Medical Systems Nederland B.V.
K173356 10/25/2017 Ingenia Elition S and Ingenia Elition X R5.4 Philips Medical Systems Nederland B.V.
K173451 11/06/2017 Ingenia Elition S and Ingenia Elition X Philips Medical Systems Nederland B.V.
K190461 02/26/2019 Achieva 1.5T, 3.0T and Intera 1.5T MR Systems Philips Medical Systems Nederland B.V.
K181479 06/05/2018 Ingenia Ambition S and Ingenia Ambition X Philips Medical Systems Nederland B.V.
K212673 08/24/2021 MR 5300 Philips Medical Systems Nederland B.V.
K172920 09/25/2017 3D APT Philips Medical Systems Nederland B.V.
K162940 10/21/2016 MultiBand SENSE Philips Medical Systems Nederland B.V.
K213583 11/12/2021 Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems Philips Medical Systems Nederland B.V.
K233853 12/05/2023 LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub Philips Medical Systems Nederland B.V.
K223918 12/29/2022 AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub Philips Medical Systems Nederland B.V.
K130842 03/27/2013 ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K131263 05/03/2013 XPERGUIDE PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K242096 07/18/2024 dS FootAnkle Coil 8ch 1.5T Philips Medical Systems Nederland B.V.
K130638 03/11/2013 ALLURACLARITY XPER FD SERIES X-RAY SYSTEM PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K133292 10/25/2013 ALLURA XPER FD; OR TABLE PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K172307 07/31/2017 Dynamic Coronary Roadmap 2.0 Philips Medical Systems Nederland B.V.
K130893 04/01/2013 XPERCT REL. 3 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K251397 05/06/2025 Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System Philips Medical Systems Nederland B.V.
K132147 07/11/2013 2D PERFUSION PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K132305 07/24/2013 STENTBOOST REL. 4 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K142126 08/04/2014 EP NAVIGATOR REL. 5.0 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K142273 08/15/2014 EmboGuide PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K233204 09/28/2023 Philips IntelliSite Pathology Solution 5.1 Philips Medical Systems Nederland B.V.
K203845 12/31/2020 Philips IntelliSite Pathology Solution Philips Medical Systems Nederland B.V.
K111245 05/03/2011 HEARTNAVIGATOR RELEASE 1 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K052078 08/01/2005 ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K102344 08/18/2010 MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K083740 12/16/2008 MAMMODIAGNOST VU PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K052013 07/26/2005 ACHIEVA 1.5T & INERA 1.5T FAMILY PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K250648 03/04/2025 Philips iCT CT system Philips Medical Systems Nederland B.V.
K212875 09/09/2021 Spectral CT on Rails Philips Medical Systems Nederland B.V.
K251808 06/12/2025 Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems Philips Medical Systems Nederland B.V.
K140138 01/22/2014 HEARTNAVIGATOR RELEASE 2.0 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K210880 03/24/2021 Vereos PET/CT Philips Medical Systems Nederland B.V.
K242512 08/23/2024 ROCC Console Philips Medical Systems Nederland B.V.
K162931 10/19/2016 Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K163116 11/07/2016 Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 Philips Medical Systems Nederland B.V.
K133819 12/16/2013 VERADIUS PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K243033 09/27/2024 dS Wrist coil 8ch 1.5T Philips Medical Systems Nederland B.V.
K221270 05/02/2022 EchoNavigator R4.0 Philips Medical Systems Nederland B.V.
K130278 02/05/2013 MR PERMEABILITY PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K140666 03/18/2014 MR ELASTOGRAPHY PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K131241 05/01/2013 SWIP PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K133526 11/15/2013 MDIXON-QUANT PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K203216 11/02/2020 The Multimodality Advanced Vessel Analysis Philips Medical Systems Nederland B.V.
K203020 10/02/2020 Spectral CT Philips Medical Systems Nederland B.V.
K201573 06/11/2020 Brain Perfusion (BP) application Philips Medical Systems Nederland B.V.
K162484 09/07/2016 Lung Nodule Assessment and Comparison Option (LNA) Philips Medical Systems Nederland B.V.
K182716 09/27/2018 Brain Perfusion (BP) application Philips Medical Systems Nederland B.V.
K162955 10/24/2016 Multi-Modality Tumor Tracking (MMTT) application Philips Medical Systems Nederland B.V.
K173467 11/08/2017 Advanced Diffusion Analysis (ADA) application Philips Medical Systems Nederland B.V.
K163250 11/18/2016 Longitudinal Brain Imaging (LoBI) application Philips Medical Systems Nederland B.V.


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